Administrative Guidance against 米国医療機器・IVD工業会

{
  "record": {
    "id": "a7cbcdbd-47af-45c7-8dc0-aea81a41e347",
    "url": "https://regbase.jp/en/enforcement/yakkiho-mi-guo-yi-liao-ji-qi-ivdgong-ye-hui-20210827",
    "company_name_original": "米国医療機器・IVD工業会",
    "company_name_registry": "米国医療機器・IVD工業会",
    "corporate_number": "2011205002084",
    "law": {
      "ja": "薬機法",
      "en": "Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices"
    },
    "action_type": {
      "ja": "行政指導",
      "en": "Administrative Guidance"
    },
    "authority": {
      "ja": "厚生労働省",
      "en": "Ministry of Health, Labour and Welfare"
    }
  },
  "entity_match": {
    "status": "confirmed",
    "confidence": 95,
    "method": "normalized_name_with_corporate_number",
    "method_label": "Normalized Japanese name matched to a company profile with Corporate Number",
    "notes": "Matched by normalized Japanese company name to an enriched company profile with a Corporate Number."
  },
  "review": {
    "status": "unreviewed",
    "label": "Machine extracted"
  },
  "compliance_context": {
    "severity": "Low-medium",
    "actionMeaning": "Administrative guidance or supervision was publicly disclosed by the authority.",
    "practicalNote": "Use as a monitoring signal. Confirm details before treating it as a formal sanction.",
    "lawContext": "Health product law covering pharmaceuticals, medical devices, cosmetics, quasi-drugs, labeling, and advertising."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/yakkiho-mi-guo-yi-liao-ji-qi-ivdgong-ye-hui-20210827",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_21919.html",
    "archiveUrl": "https://kiroku.today/view/2077ea6711s81bk3",
    "archiveCapturedAt": "2026-05-05T06:02:17.79+00:00",
    "extractedAt": "2026-05-05T06:02:17.134+00:00",
    "translatedAt": null,
    "evidenceCheckedAt": "2026-05-05T06:02:17.134+00:00",
    "generatedAt": "2026-06-24T21:34:35.098Z"
  },
  "limitations": [
    "RegBase aggregates public Japanese government disclosures and does not provide a credit opinion.",
    "English summaries are provided for reference. The original Japanese source is authoritative.",
    "Possible or unresolved entity matches should be manually verified before use in a decision."
  ]
}